STRIDES PHARMA EIR
Strides Pharma Science shares jump 9% after USFDA EIR for Bengaluru facility
Strides Pharma Science shares rise sharply on Thursday after the USFDA issued an Establishment Inspection Report (EIR) for its Bengaluru facility, concluding a recent cGMP inspection. The inspection ended with five observations, which the company addressed through corrective actions. The regulatory closure offers relief after the stock’s recent weakness.
Strides Pharma's Chestnut Ridge unit in New York classified as voluntary action indicated by USFDA
Strides Pharma Science announced its US subsidiary, Strides Pharma Inc, has received a Voluntary Action Indicated classification from the USFDA. This follows an inspection of its formulations unit in Chestnut Ridge, New York. The inspection covered Good Manufacturing Practices and drug-device combination capabilities. The facility supports the US market with various product types.
Stelis Biopharma receives establishment inspection report from USFDA
This follows the abbreviated quality system inspection technique drug pre-approval on-site inspection specifically conducted by the US Food and Drug Administration (USFDA) for the drug-device combination products that are to be manufactured and commercialised at the site for the partner products by Stelis, it said in a regulatory filing.
USFDA clears four Indian manufacturing plants in 10 days
India’s leading drug companies have had their manufacturing facilities cleared in the last 10 days by the US Food and Drug Administration (USFDA), a decision that comes at a time when supply-chain disruptions due to the Covid-19 pandemic are causing drug shortages across the world.
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Hold Strides Pharma, target price Rs 357: Geojit
The move to front end sales and systematic product launches in the US will be key triggers for the company in the future.
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Reliance Industries was the biggest culprit for Monday’s fall, as it bled 146.67 points.
USFDA in active mode, issues obersvations to 4 drug makers in 3 days!
SMS Pharma today informed exchanges that the United States Food and Drug Administration (USFDA) conducted a cGMP inspection at Kandivalasa, Vipanagaram, Andhra Pradesh API manufacturing facility from January 13-17.
Strides arm receives EIR for its US facility
The facility is one of the very few manufacturing facilities in the US with a soft gel capsule (SGC) manufacturing suite for formulations with containment needs, the company said. Strides has a portfolio of approved SGCs in the US and other regulated markets.
Strides Pharma gets USFDA inspection report for Alathur unit with no adverse observations
The company said the company's formulations unit in Alathur was inspected by the US Food and Drug Administration (USFDA) in August without any adverse observations.
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